Dive Brief:
- Freeline Therapeutics is selling a subsidiary, halting investment in an experimental hemophilia treatment and laying off staff to preserve enough cash to keep operations going into 2024.
- The U.K. biotech on Tuesday said it had agreed to sell its German unit, Freeline Therapeutics GmbH, to Ascend Gene and Cell Therapies for $25 million. As part of the deal, Freeline will get a back-license to rights it needs to develop its experimental treatments and pay Ascend at least $7.9 million over 18 months as part of a service agreement that includes access to certain capabilities and personnel.
- Freeline is also reducing its workforce in the U.S. and U.K. by about 30 people. With those cuts and the transfer of workers in Germany to Ascend, the company expects to have 100 employees by the end of the year.
Dive Insight:
Freeline is narrowing its focus to two product candidates: FLT201 for Gaucher disease and FLT190 for Fabry disease. The two experimental gene therapies “have the greatest potential to benefit patients and drive value for shareholders,” CEO Michael Parini said in the company’s statement Tuesday.
The strategy means Freeline will stop development of a hemophilia B treatment called FLT180a unless it can find a partner. Though the company has released promising data for the hemophilia therapy, it has yet to advance it into Phase 3 testing. A rival therapy from CSL Behring and UniQure may win Food and Drug Administration approval as early as this month.
When Freeline announced it was considering options including a partner for its hemophilia treatment in July, the company drew a distinction between that drug and the Gaucher and Fabry therapies. While the hemophilia therapy still had the potential to be a “best-in-class” treatment, the other medicines had a chance to be first in their class, Freeline said.
This is the second time in less than a year that Freeline has trimmed research and laid off staff. In December 2021, the company announced plans to cut 25% of its workforce and stop development of a preclinical therapy for hemophilia A, the more common type of the bleeding disorder.
Gene therapies hold great promise for hemophilia, but the path for developers has been rocky at times. The FDA in 2020 rejected an application from BioMarin Pharmaceutical for approval of its hemophilia A treatment, and has temporarily halted studies over concerns of cancer risk.
BioMarin recently submitted a new application, which the FDA has said it will review by the end of March. A request to see additional data may further delay that assessment, however.